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Help For Medical Inventors

It's no secret that start-up companies face an uphill battle to get their ideas funded and turned into salable products. But they need not go it alone. A few communities have formed organizations aimed at assisting start-ups. In Orange County, Calif., for example, Octane LLC (octaneoc.org) aims to bring start-up hopefuls in the biomedical field together with venture capitalists, along with contract manufacturers willing to assist. “If an idea needs further research, we put them in touch with talented people at UC Irvine,” says Gary Augusta, Octane president and CEO. The organization's goal is to create more biomedical and technology companies, engines that drive the economy. He says in Orange County there are about 800 medical companies.

Augusta admits that not every idea gets funded. Out of 250 intellectual property (IP) holders that have approached his group this year, 21 have gotten assistance amounting to some $42 million.

Contract developers and manufacturers might be another place to turn for assistance. CEO of diagnostic machine-builder Source Scientific LLC, Richard Henson, says several OEM clients use the wet lab at his Irvine facilities. “A small lab here lets them do experiments and then turn to our engineers with questions. It's a great way to collaborate,” he says.

Navigating the complex federal regulations is another good reason to work with a contract manufacturer. Regulations are becoming more complex along with the equipment. Design controls, an example of growing federal influence, are FDA guidelines intended to document the decision making behind the design process. Henson says his company assists with monitoring regulations for clients, something most start-ups are unfamiliar with.

President of Aubrey Group Inc, Vytas Pazemenas, also in Irvine (aubreygroup.com) says part of their pro bono services is to guide start-ups around regulatory hurdles. “We would first describe what it will take to develop the idea along with a cost, then help develop a list of deliverables for the FDA,” says Pazemenas. One device, a blood pump, was developed after an inventor came in with only a drawing. “A specification went through several iterations before we built two pumps for clinical tests. And that only took 12 weeks,” he says. “If someone comes in with an idea but no funding, we can direct them to VCs, usually through Octane.”

Pazemenas adds that a product's success is also based on trust and respect between IP holder and contract developer and manufacturer. “It's hard to work without those,” he says. And expect the manufacturers to correct and change some of your initial design so it's easier to manufacture. His company also gives space to start-ups and clients in the name of collaboration. Pazemenas cautions start-ups to be patient. “Although we've turned a few ideas into working prototypes in as little as 10 weeks, most projects span eight months to two years.

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© 2012 Penton Media Inc.


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